Contraceptive and Acne Medication Combination and Treatment of Acne and Other Diseases with Reduced Side Effects

Abstract

The present invention provides pharmaceutical compositions for the treatment of acne, psychotic illnesses, such as schizophrenia, cancer, such as cancer of the head, neck and lung, and emphysema, comprising co-administering a therapeutically effective amount of isotretinoin and a contraceptive in a contraceptively effective dosage. The contraceptive preferably does not contain 100 wt % progestogen. Methods of treating acne and unit dosage delivery systems are also provided. Also provided is an improved method of treating acne, and other diseases, comprising providing a blister pack comprising at least about 28 separate daily dosage units of a therapeutically effective amount of isotretinoin, or other retinoic acid derivative equivalent, and at least about 21-28 additional daily dosage units of an oral contraceptive in a contraceptively effective amount, selected from the group consisting essentially of: estrogen, estrogen and progestogen, mifepristone, or a combination thereof, whereby for at least about 21 successive days, said oral dosage unit of isotretinoin, or other retinoic acid derivative equivalent, and said oral dosage unit of said oral contraceptive are administered to a female of child-bearing age. Patch, inhaler, nebulizer, and injection formulations for the preferred active ingredients are also provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application is a continuation-in-part of U.S. application Ser. No. 11 / 380,446, filed Apr. 27, 2006 (Attorney Docket D0968-00072).FIELD OF THE INVENTION[0002]The present invention is related to acne treatments and compositions for treating acne, and especially those that are designed to minimize birth defects in patients being treated with isotretinoin.BACKGROUND OF THE INVENTION[0003]The treatment of acne can be summarized into established tiers of care, beginning with topical remedies including topical benzoyl peroxide 5-10% and / or topical antibiotics and retinoic acid (Retin-A®), followed by tretinoin, oral antibiotics, hormone-related therapy, and finally, isotretinoin (Accutane®, Amnesteem®, Claravis® and Sotret®).[0004]Oral antibiotics, such as tetracycline, erythromycin, taken by mouth, are usually a critical step in the treatment of acne. Antibiotics limit the growth of acne and decrease redness and inflammation. Over t...

AI Technical Summary

Benefits of technology

[0020]The present invention is designed to counter the teratogenicity associated with current isotretinoin therapy. Because the pharmaceutical composition of this invention contains both isotretinoin and a contraceptive together in a daily or bi-daily dosage, the patients taking this therapy, and especially those that take an oral contraceptive for 28-56 days beforehand, are substantially prevented from conceiving. This treatment option will limit the risk of birth defects caused by patents taking isotretinoin alone, without birth control, or by physicians who prescribe isotretinoin to patients who may not be admitting that they are sexually active.

Problems solved by technology

Over time, however, resistance to these drugs can occur.

These medications often increase one's sensitivity to sun's ultraviolet rays, and rash is a common side effect in those exposed to sunlight while taking the medications.

While it is an incredible medication for treating acne, it is a “big gun” and can cause a number of bothersome, serious, and even deadly side effects.

Therefore, it is possible and perhaps likely that the currently used schedule is in fact excessive therapy for a portion of acne patients who have less severe, but antibiotic resistant disease.

Nevertheless, even one dose of isotretinoin given to a pregnant woman can produce birth defects, so the lowered risk of teratogenicity may not be low enough.

With increased economic pressures exerted upon physicians' offices by managed care programs, the hour or so needed for each Accutane®-treated female patient is a heavy burden.

Additionally, a substantial problem exists when dealing with teen-age girls or single women who may deny they are sexually active, since physicians are reluctant to disbelieve their patients.

Images